DIN EN ISO 13485

DIN EN ISO 13485

ISO 13485is an ISO standard which was first published in 2003. It describes the necessity for a comprehensive management system for the design and manufacture of medical devices. This standard addresses organisations which are required to meet a European Directive for medical products (90/385/EEC and 98/79/EC) to apply the CE symbol to their products. This standard replaces earlier valid documents such as ISO 46001, ISO 46002 and ISO 13488.

Despite being an independent document, ISO 13485 was adjusted to ISO 9001. One fundamental difference is that ISO 9001 demands a continuous improvement process, whereas ISO 13485 only requires that a quality management system exist, be implemented and maintained. Further differences:

The promotion and consciousness of legal requirements as a management responsibility, the intent to provide resources and determine appropriate methods and processes.

Inspections in the working environment to assure product safety

Examination of risk management, activities and transitional design activities during product development

Specific requirements for control and traceability

Specific requirements for records and documents

Specific requirements for checking the effectiveness of collective and preventive tasks

ISO 13485 certification is frequently regarded as the first step towards attaining conformity with European directives. Medical devices and in-vitro diagnostics should successfully demonstrate their conformity with EU Directive 93/42/EEC, 90/385/EEC and 98/79/EEC in a conformity evaluation process before they can be launched on the market in the European Union. The preferred means of verifying conformity is certification of a quality management system pursuant to ISO 9001 and/or ISO 13485 by a designated body. The result is a positive evaluation, the power to label products with the CE symbol and, simultaneously, the permission to introduce superior-quality medical devices for sale in the European Union.